Isihloko
Amakhaphsuli namathebhulethi e-methylene blue uma kuqhathaniswa namaconsi awuketshezi
Amakhaphsuli namathebhulethi e-methylene blue ahlinzeka ngeyunithi esikalwe kusengaphambili. Amaconsi awuketshezi adinga ukwazi ukugxila kwento kanye nomthamo woketshezi osikaliwe ukuze kutholakale inani lento. Lowo mehluko osebenzisekayo ucacile. Ukuthi yiluphi uhlobo oluletha i-methylene blue eningi egazini kuwumbuzo ohlukile odinga ubufakazi mayelana nokwakheka komkhiqizo othile.
Ikhaphsuli, ithebhulethi, umucu womlomo, noma iphilisi elincibilikiswa emlonyeni kuyindlela yokuletha into emzimbeni, hhayi izinga lekhwalithi. Ukuma okulula ukukusebenzisa akukwazi ukuqinisekisa ukuthi isithako siyilokho okuthiwa siyikho, ukuthi okuqukethwe kunembile, ukuthi kunenzuzo yezokwelapha, noma ukuthi kuwufanele umuntu othile. Qhathanisa leyo mibuzo ngokwehlukana ngaphambi kokukhetha uhlobo.
Yini eshintshayo lapho i-methylene blue iba yiphilisi?
Ikhaphsuli ivalela okuqukethwe ngaphakathi kwegobolondo. Ithebhulethi icindezela izithako zibe yiyunithi eqinile, ngezinye izikhathi ibe nesimbozo. Izithako ezisizayo ziyizithako ezingeyona into esebenzayo: zingandisa ubukhulu, zibambe ithebhulethi ihlangene, ziyisize ihlakazeke, noma zilawule ukukhululwa kwento. Ukuba khona kwazo akubona ngokuzenzakalelayo ubufakazi bekhwalithi ephansi. Kufanele kudalulwe ukuthi ziyini nokuthi zenzelweni.
Ingxube ewuketshezi ethathwa ngomlomo isuke isiqukethe into encibilikile, ngakho ayidingi ukuthi igobolondo lekhaphsuli noma ingaphakathi lethebhulethi kuhlakazeke. Lokho kususa isinyathelo esisodwa sokwakheka komkhiqizo; akufakazeli imiphumela yezokwelapha esheshayo noma ukumuncwa okuphelele okukhulu. Ukwakheka komkhiqizo kusenakho ukugxila kwento, ezinye izithako, ukupakishwa, nezidingo zokugcinwa.
Indlela yokukhululwa kwento nayo ingahlelwa ngenhloso. Incazelo ye-EMA nge-Lumeblue ibhala ngethebhulethi ye-methylene blue edinga incwadi kadokotela, esetshenziselwa ukuthuthukisa ukubonakala ngesikhathi sokuhlolwa kwekholoni. Isimbozo sayo nokukhululwa kancane kusiza ukuletha udayi ekholoni. Lona ngumuthi othile wokuxilonga onenjongo ethile. Ukuba khona kwawo akuqinisekisi ithebhulethi ethengiswa ezitolo ngenjongo engahlobene naleyo, futhi indlela yawo yokukhulula into akufanele kuthiwe iyafana kuyo yonke imikhiqizo ebizwa ngokuthi yithebhulethi.
Lokho ucwaningo lokumuncwa olungakutshela khona ngempela
Ocwaningweni lwesigaba I luka-Walter-Sack nozakwabo, amavolontiya anempilo angu-16 abamba iqhaza ekuqhathaniseni okwabiwa ngokungahleliwe, lapho umuntu ngamunye ethola zombili izinhlobo ngezikhathi ezihlukene: i-methylene blue efakwa emthanjeni kanye nengxube eyenziwe ngamanzi ethathwa ngomlomo. Abacwaningi babika isilinganiso sokutholakala emzimbeni okuphelele esingu-72.3%, esinokuchezuka okujwayelekile okungu-23.9%. Ukutholakala emzimbeni okuphelele kulinganisa ukuthi kungakanani okufinyelela ekujikelezeni kwegazi kuwo wonke umzimba uma kuqhathaniswa nokufakwa emthanjeni, kucatshangelwa amanani afakiwe.
Lokhu kusekela ukumuncwa okukhulu kwaleyo ngxube eyenziwe ngamanzi eyahlolwa ngaphansi kwalezo zimo. Akuvezi iphesenti elisebenza kuwo wonke amabhodlela aneziconsisi. Lolu cwaningo futhi aluzange luqhathanise ngokuqondile amakhaphsuli, amathebhulethi, imicu yomlomo, namaphilisi ancibilikiswa emlonyeni athengiswa ezitolo namuhla.
Ukuqhathanisa izifundo ezingahlobene kungadukisa lapho umthamo, ababambiqhaza, izimo zokudla, uhlelo lokuthatha amasampula, noma indlela yokuhlaziya kwehluka. Iphesenti eliphakeme elibikwe kwelinye iphepha locwaningo alanele ukubeka imikhiqizo emibili ethengiswayo ngokulandelana kokuthi yimuphi ongcono.
Isiqondiso se-ICH M13A ngokulingana kokutholakala emzimbeni sichaza ukuthi kungani ukuqhathaniswa kwemikhiqizo kuhlola izilinganiso zokuchayeka emzimbeni, njengokugxila okuphezulu kanye nendawo engaphansi kwejika lokugxila ngokuhamba kwesikhathi. Ukugxila okuphezulu kuchaza izinga eliphakeme kakhulu elikaliwe; indawo engaphansi kwejika ifingqa ukuchayeka ngokuhamba kwesikhathi. Ukwakheka komkhiqizo kungashintsha isikhathi sokuchayeka ngaphandle kokushintsha ubungako bako obuphelele ngesilinganiso esifanayo.
Kumthengisi othi umkhiqizo umuncwa kangcono, cela ukwakheka okuphelele komkhiqizo ohloliwe, indlela yokuwufaka emzimbeni, lokho oqhathaniswe nakho, iqembu labantu abafundiwe, kanye nesilinganiso somphumela esikaliwe. Ividiyo yokuncibilika ibonisa into ihlakazeka. Ayikali ukumuncwa kumuntu.
Ukuqhathanisa izinhlobo: amalebula, izithako, ubufakazi, nokuphathwa
Leli thebula liyinsiza yokuthenga, hhayi ukuhlelwa ngokusebenza kwezokwelapha. Okubhalwe kulo kuchaza okufanele ukuhlolwe; imikhiqizo yangempela iyehluka.
| Uhlobo | Ukulebulwa komthamo okufanele kuhlolwe | Izithako ezisizayo okufanele zihlonzwe | Imibhalo okufanele icelwe | Umehluko ekuphathweni |
|---|---|---|---|---|
| Ikhaphsuli | Ama-milligram kukhaphsuli ngayinye nenani lamakhaphsuli esilinganisweni sokusetshenziswa esishiwo | Into okwenziwe ngayo igobolondo, izithako zangaphakathi, izinto ezisebenzayo ezengeziwe | Ukuhlolwa kwenani lento kuyunithi eqediwe, ukufana kokuqukethwe, ulwazi lokukhululwa kwento, ukuhlonza iqoqo lokukhiqiza | Iyunithi engaguquki elula ukuyiphatha; izidingo zokugwinya nemiyalelo yokuyivula kubalulekile |
| Ithebhulethi | Ama-milligram kuthebhulethi ngayinye; ukukhululwa ngokushesha, okubambezelekile, noma okuqhubeka isikhathi eside; noma yikuphi ukuhlukaniswa okuqinisekisiwe | Izithako ezibophayo, ezandisa ubukhulu, ezisiza ukuhlakazeka, ezithambisayo, isimbozo | Ukuhlolwa kwenani lento, ukufana, ukuhlakazeka noma ukuncibilika lapho kufanele khona; ubufakazi bokuhlukanisa uma kushiwo ukuthi kuvumelekile | Akukho ukulinganiswa koketshezi; ukuchoboza noma ukuhlukanisa kungashintsha ukulethwa kwento emzimbeni |
| Amaconsi awuketshezi | Ama-milligram nge-milliliter, isisekelo esichaziwe sokugxila kwento, umthamo woketshezi wesilinganiso sokusetshenziswa osikaliwe | Uketshezi oluncibilikisayo, izilondolozi, izinongo zokunambitha, ezinye izinto ezisebenzayo | Ukugxila kwento engxubeni eqediwe, ukuhlolwa okufanele kokungcola namagciwane, ulwazi lokupakishwa nokuzinza | Kudinga ukukalwa; ukuchitheka nokushiya amabala lapho kuthintana nezinto kuyizinto ezingokoqobo okufanele zicatshangelwe |
| Umucu womlomo | Ama-milligram emucwini ophelele ngamunye nenani lemicu esilinganisweni sokusetshenziswa | Izithako ezakha ungqimba oluncane, izithako ezenza luthambe, izithako ezenza kube mnandi, izinongo zokunambitha | Ukufana kokuqukethwe kweyunithi, ukuzinza, ukuhlakazeka; imininingwane evela kubantu nganoma yisiphi isimangalo sokumuncwa | Iyunithi encane; imiyalelo yokupakishwa neyomswakama ibalulekile; ungacabangi ukuthi ukusika kugcina ukunemba komthamo |
| Iphilisi elincibilikiswa emlonyeni | Ama-milligram ephilisini ngalinye, ubungako besilinganiso sokusetshenziswa, indlela ehlosiwe yokulifaka emzimbeni | Isisekelo sikashukela noma esingenashukela, izithako ezibophayo, izinongo zokunambitha, izinto ezisebenzayo ezengeziwe | Ukufana kokuqukethwe kweyunithi, indlela yokukhululwa kwento, ubufakazi obuvela kubantu obuqondene nendlela yokulifaka emzimbeni | Lincibilika emlonyeni; isikhathi sokuthintana nendlela yokugwinya kwehlukile kokwekhaphsuli engavuliwe |
Ungakwazi ukulanda iphepha lokuqhathanisa nelokuhlola umphakeli ukuze ubhale ubufakazi bemikhiqizo emibili ocabanga ukuyikhetha.
Funda iyunithi ngaphambi kokuqhathanisa inombolo
“Ama-milligram esilinganisweni sokusetshenziswa” kungase kubhekisele kumakhaphsuli noma emicwini eminingana. “Ama-milligram ebhodleleni” kubhekisele kuso sonke isitsha. Akukho kulokhu okuchaza ngokuzenzakalelayo iyunithi eyodwa. Ngoketshezi, inani lento engxenyeni esikaliwe litholakala ngokuphindaphinda ukugxila kwento ngomthamo woketshezi; ukubalwa kwamaconsi kudinga ubudlelwano obuqinisekisiwe nomthamo woketshezi kusetshenziswa isikhiphi esinikeziwe.
Ilebula eliyisibonelo elithi “12 mg esilinganisweni sokusetshenziswa; ubungako besilinganiso sokusetshenziswa ngamakhaphsuli angu-3” lisho ukuthi kukhona u-4 mg kukhaphsuli ngayinye, uma okuqukethwe kuhambisana nelebula. Alisho ukuthi kukhona u-12 mg kukhaphsuli ngayinye. Lokhu ukubala ngokwelebula, hhayi inani elinconyiwe okufanele lithathwe.
Buza ukuthi ama-milligram ashiwo asekelwe kuyiphi into lapho amalebula noma izitifiketi zicacisa izinhlobo zamakhemikhali ezihlukene noma izindlela ezihlukene zokubika ukuhlolwa kwenani lento. Ukuqhathanisa amanani amabhodlela ngaphambi kokucacisa iyunithi nokuthi ikhemikhali iyini kungaholela ekuqhathaniseni inani elitholakalayo okungenamqondo.
Amayunithi asikalwe kusengaphambili nawo ancike ekungaguquguqukeni kokukhiqiza. Ukuhlolwa kwenani lento emathiriyelini ahlanganisiwe kungachaza isilinganiso kuyilapho kushiya kungaphenduliwe ukwehluka phakathi kwamayunithi. Umbuzo uwukuthi amayunithi aqediwe ngamanye ahlangabezana njalo yini nokucaciswa okushiwo, hhayi nje ukuthi isithako esingakacutshungulwa siphumelele yini ukuhlolwa kobumsulwa.
Imicu namaphilisi ancibilikiswa emlonyeni: ukuncibilika akuwona umphumela wokumuncwa
“Ngomlomo,” “ngaphansi kolimi,” nokuthi “ngaphakathi esihlathini” akuzona izincazelo ezingasetshenziswa esikhundleni sezinye. Ukubekwa ngaphansi kolimi kusho lokho kanye; ukubekwa ngaphakathi esihlathini kubhekisela ekubekeni into ithintane nengaphakathi lesihlathi. Umkhiqizo oncibilika ematheni ungase ube usugwinywa. Ukunyamalala kwawo emlonyeni akuqinisekisi ukuthi kungakanani okudlule olwelwesini lwamafinyila lomlomo.
Isiqondiso se-FDA ngamathebhulethi ahlakazeka emlonyeni sibheka ukuhlakazeka njengesici sohlobo lomuthi. Akusona isitifiketi sokutholakala emzimbeni okungcono. Ngemicu noma amaphilisi ancibilikiswa emlonyeni e-methylene blue, cela ubufakazi obuvela kubantu bokuhamba nokucutshungulwa kwento emzimbeni, kusetshenziswa ukwakheka komkhiqizo uqobo nendlela ehlosiwe yokuwufaka emzimbeni. Imithombo etholakele yalokhu kuqhathanisa ayizange iqinisekise ukuthi imicu noma amaphilisi ancibilikiswa emlonyeni athengiswayo angcono kunamakhaphsuli noma uketshezi.
Hlola zonke izithako kunokuba ubheke isimangalo esithi “akunashukela” noma “kuncibilika ngokushesha” njengencazelo ephelele yokwakheka komkhiqizo. Amaswidi athambile e-methylene blue anemibuzo yawo ngezithako nokuhlolwa.
Khetha ukufaneleka okubhalwe ngobufakazi, bese ukhetha ukusebenziseka kalula
Ungazenzeli izingxenye zamayunithi ngokuvula amakhaphsuli noma ngokusika imicu. Ngamathebhulethi, iseluleko se-FDA sokuhlukanisa amathebhulethi sichaza ukuthi umkhiqizo ongenayo imiyalelo yokuhlukanisa ehloliwe awukaze ngempela ubonise ukuthi izingxenye zawo ezimbili zinokuqukethwe komuthi okulinganayo noma ziziphatha ngendlela efanayo. Imikhiqizo eyakhelwe ukukhulula into ngendlela eguquliwe idinga ukunakekelwa okukhethekile.
Ukushintsha uhlobo nakho akususi indlela i-methylene blue esebenza ngayo emzimbeni. Ukuhambisana neminye imithi kusabalulekile; sebenzisa isiqondiso sokusebenzisana kwe-methylene blue neminye imithi lapho ulungiselela imibuzo kadokotela noma usokhemisi. Umkhiqizo wokuxilonga we-EMA othathwa ngomlomo nawo unezimo lapho ungafanele usetshenziswe khona, kuhlanganise nokushoda kwe-G6PD nokukhulelwa, okubonisa ukuthi “ngomlomo” akusho ukufaneleka ngaphandle kwemikhawulo.
Esinqumweni sokuthenga, qala ngokucacisa ukusetshenziswa okuhlosiwe, isimo somkhiqizo ngokomthetho, ukulebulwa okucacile, nobufakazi bomkhiqizo oqediwe obuxhunywe eqoqweni lokukhiqiza. Bese uqhathanisa ukugwinya, ukukala, ukuphatheka kalula, izithako, nokupakishwa nesidingo sangempela. Uhlu lokuhlola lokuqhathanisa lomthengi lunikeza uhlaka olubanzi lwekhwalithi. Ikhaphsuli ingase ixazulule inkinga yokuphathwa; uketshezi lungase luhlangabezane nesidingo sokukala. Akukho kulokho okutholakele okuqinisekisa ukulingana kokumuncwa noma inzuzo yezokwelapha.